Phase 2
N=98
Effects of Methylene Blue in Healthy Aging, Mild Cognitive Impairment and Alzheimer's Disease
Mild Cognitive Impairment · MCI · Aging · Alzheimer's Disease · AD
Bottom Line
View on ClinicalTrials.gov: NCT02380573 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: fMRI Measurement — 2267.0; 1491.23; 673.31; 989.19 voxels
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methylene Blue (Drug); FD&C Blue # 2 (Drug); Phenazopyridine hydrochloride (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY fMRI Measurement |
2267.0; 1491.23; 673.31; 989.19; 1719.00; 962.69 | — |
| PRIMARY Wechsler Memory Scale, Third Edition |
14.58; 15.43; 15.23; 13.06; 4; 15 | — |
| PRIMARY fMRI During FNAME |
16881.03; 17382.29; 13166.23; 13777.75; 2211.00; 3938.00 | — |
| PRIMARY FNAME |
14.5; 14.36; 10.54; 11.19; 8; 6 | — |
| PRIMARY fMRI During Psychomotor Vigilance Task |
271.33; 150.79; 145.00; 56.94; 175.08; 129.00 | — |
| PRIMARY Psychomotor Vigilance Task |
399.9; 382.7; 408.1; 482.4; 744.8; 631.04 | — |
| PRIMARY Wechsler Memory Scale III, Logical Memory Subset |
47; 43.5; 32.4; 37.48; 25; 5 | — |
| PRIMARY Mini-Mental State Exam (MMSE) |
29; 29.32; 27.76; 27.52; 21; 21 | — |
| PRIMARY CLOX: An Executive Clock Drawing Test |
.89; 1; 1.86; 1.52; 1; 1 | — |
| SECONDARY Cerebral Blood Flow Measures |
34.65; 37.9; 31.97; 35.2; 95.13; 4.02 | — |
Summary
A double-blind, placebo-controlled study that aims to investigate the effect of 2-week and 12-week administration of USP methylene blue (MB) on cerebral blood flow, functional connectivity, memory and attention cognitive abilities using fMRI and behavioral measures in healthy aging, mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) subjects.
Eligibility Criteria
Inclusion Criteria for all subjects:
- 45-89 years old
- All genders
- All minorities
- English, Spanish, or multilingual speakers
- Postmenopausal or surgically sterile females only.
- Inclusion for MCI group only: participants will meet the criteria for amnestic and non-amnestic MCI such as those currently used by Texas Alzheimer's Research and Care Consortium (TARCC) consensus diagnosis
- Inclusion for AD group only: Alzheimer's Early-stage, sporadic-type
Exclusion Criteria
- Pregnancy or breastfeeding
- Contraindication for MRI (Claustrophobia and magnetic metal implants)
- Glucose-6-phosphate deficiency, methemoglobinemia
- Allergy to MB
- Color-blindness
- Craniotomy, craniectomy or endovascular neurosurgery
- A current diagnosis of stroke, transient ischemic attack (TIA), any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances or secondary dementia (MCI or AD does not exclude subject)
- A serious intercurrent illness likely to cause death within the next 5 years, such as terminal cancer
- Alcohol and/or drug abuse
- Any detection of an unknown disease process (eg. new tumor) on the study's neuroimaging at the discretion of the investigators
- A systolic blood pressure ≥180 mmHg and/or a diastolic blood pressure ≥105 mmHg
- Severe difficulty or an inability to perform any one of the 6 Katz Activities of Daily Living
- Patients who are unlikely to comply with trial visit schedule or with trial medication,
- On any psychiatric serotonergic antidepressant medication or psychotropic medication within the last 5 weeks
- Diagnosis of epilepsy, traumatic brain injury with loss of consciousness, psychosis, panic attacks,
- Chronic kidney disease, cirrhosis, liver or renal transplants
- Known hypersensitivity to thiazide diuretics and phenothiazines
- Any other condition, which in the opinion of the investigator, would put the participant at risk and warrant exclusion from the study
Data sourced from ClinicalTrials.gov (NCT02380573). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.